HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13)
today announces that new and updated clinical data related to
HUTCHMED’s novel investigational cancer therapies fruquintinib,
surufatinib and HMPL-453 in 21 abstracts that will be presented at
the upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting, taking place June 2-6, 2023 in Chicago, IL and online.
Fruquintinib: further analyses from the
FRESCO-2 study and exploratory combination studies
Fruquintinib is a highly selective and potent
oral inhibitor of vascular endothelial growth factor receptor
(“VEGFR”)-1, -2 and -3.1 Fruquintinib has been generally well
tolerated in patients to date and is being investigated as a single
agent and in combination with other anti-cancer therapies. 13
presentations and publications, including several
investigator-initiated-trials (“IITs”), are listed in the table
below.
Additional FRESCO-2 analyses: New analyses from
the FRESCO-2 multi-regional clinical trial (MRCT) are being
presented. FRESCO-2 is a key study supporting ongoing and upcoming
submissions to the U.S., European and Japanese regulatory
authorities for the treatment of previously treated metastatic
colorectal cancer (“CRC”). FRESCO-2 results were first presented at
the European Society for Medical Oncology Congress 2022. These new
analyses add to the understanding of fruquintinib efficacy by
specific lines of therapy as well as adverse events of special
interest (“AESI”). In subgroup analyses by prior lines of therapies
up to six or more and by prior treatment with approved agents,
fruquintinib improved overall survival (“OS”) and progression free
survival (“PFS”) for all subgroups and prior therapies, consistent
with those of the intent-to-treat (“ITT”) population. Furthermore,
during the study AESIs led to low rates of dose reduction (13.6%
for patients who received fruquintinib vs 0.9% for patients who
received placebo) and dose discontinuation (8.3% for patients who
received fruquintinib vs 6.1% for patients who received
placebo).
CRC real-world data: Results from a prospective,
3,005-patient Phase IV study to evaluate the safety of fruquintinib
in real-world clinical practice in China are consistent with the
fruquintinib safety profile observed in existing clinical studies,
with no new or significant safety signals identified.
PD-1 combination in ccRCC: PFS results from an
exploratory study of the fruquintinib and sintilimab (an
anti-programmed cell death protein-1 [“PD-1”] antibody) combination
in metastatic clear cell renal cell carcinoma (“ccRCC”) are
available with longer term follow-up. At data cut-off on November
30, 2022, median PFS was 15.9 months in 20 previously treated
patients. Median PFS was not reached when results from this study
were initially presented at the 2021 Chinese Society of Clinical
Oncology Annual Meeting (data cut-off on August 31, 2021). No new
safety signals were observed. A Phase II/III trial of fruquintinib
in combination with sintilimab as second-line treatment for locally
advanced or metastatic ccRCC was initiated in October 2022
(NCT05522231).
IIT in 2L MSS CRC: A number of IITs are being
presented, including initial results of an IIT for fruquintinib in
combination with investigator's choice of chemotherapy in
second-line metastatic CRC with microsatellite-stable (MSS)
phenotype. At median follow up of 8.4 months, median PFS was not
reached in 31 efficacy evaluable patients, disease control rate
(DCR) was 90.3% and objective response rate (ORR) was 48.4%. Five
patients received reduced doses of fruquintinib.
Surufatinib: exploratory results in
combination with other agents
Surufatinib is a small-molecule inhibitor of
VEGFR-1, -2 and -3, fibroblast growth factor receptor (“FGFR”)-1
and colony-stimulating factor 1 receptor (CSF-1R). Seven related
presentations and publications, including IITs, are listed in the
table below.
PD-1 combinations: We conducted an open-label,
multi-cohort, single-arm Phase II study of surufatinib plus
toripalimab (an anti-PD-1 antibody) in several advanced solid
tumors. We reported the results from the advanced thyroid cancer
and endometrial cancer cohorts (NCT04169672). Amongst efficacy
evaluable radioactive iodine-refractory differentiated thyroid
cancer patients, median PFS was 10.9 months and median OS was not
reached (median follow-up duration was 22.1 months). Amongst
efficacy evaluable endometrial cancer patients, median PFS was 5.4
months and 12-month OS rate was 71.0% (median follow-up duration
was 16.8 months). In both cohorts, the combination showed a
tolerable safety profile.
Combo IITs: A number of IITs are being presented
for surufatinib in combination with other agents, including with
chemotherapy as well as with camrelizumab (an anti-PD-1 antibody)
plus different chemotherapy regimens.
Preliminary results in an ongoing IIT in
treatment of patients with naïve metastatic pancreatic
adenocarcinoma (PDAC) showed median PFS of 8.8 months in patients
who received a combination of surufatinib, camrelizumab,
nab-paclitaxel and S-1, compared to 5.8 months in patients who
received gemcitabine in combination with nab-paclitaxel. Markers of
immune cells were observed in an analysis of tissue samples from 13
(out of 20) patients who received S-1 in combination with
surufatinib, camrelizumab and nab-paclitaxel. The combination
safety profiles were manageable.
The IIT in previously treated CRC study
completed the dose escalation phase of the study in 12 patients and
enrolled a further 36 patients in the dose expansion phase of the
study. The investigators found the combination of surufatinib with
camrelizumab, irinotecan and GM-CSF to be well tolerated with a
manageable safety profile. Median PFS was 7.2 months (95% CI
3.7-10.7).
The IIT in previously treated, advanced
driver-gene negative, non-squamous, non-small cell lung cancer
(“NSCLC”) in combination with chemotherapy. This study complements
Phase II results previously presented for the surufatinib and
toripalimab combination in patients with treatment naïve advanced
NSCLC with positive PD-L1 expression.
HMPL-453: first in human
results
FGFRs regulate numerous cellular processes.
Dysregulation of FGFR signaling due to receptor fusion, mutation or
amplification is observed across multiple cancer types, making
activated FGFRs an important therapeutic target. HMPL-453 is a
highly potent and selective inhibitor of FGFR-1, -2, and -3.
Preclinical data presented at the American Association for Cancer
Research Annual Meeting 2023 (AACR 2023) showed that it has strong
activity against FGFR-deregulated tumors, supporting investigation
in patients with FGFR alterations (such as fusion and mutation)
either as a single agent or in combination with PD-1 blockade.
Here we present first-in-human data for HMPL-453
in patients with previously treated advanced intrahepatic
cholangiocarcinoma (IHCC) harboring FGFR2 fusions. A Phase II
registration intent cohort is currently enrolling such patients
(NCT04353375).
Further details including the full abstracts are
available at meetings.asco.org, as summarized below.
ABSTRACT PRESENTATION
DETAILS
Abstract title |
Presenter / Lead author |
Presentation details |
FRUQUINTINIB |
Subgroup analyses of safety and efficacy by number and
types of prior lines of treatment in FRESCO-2, a global phase III
study of fruquintinib in patients with refractory metastatic
colorectal cancer |
Arvind Dasari, MD Anderson Cancer Center |
Abstract # 3604 Poster SessionGastrointestinal Cancer–Colorectal
and AnalMonday, June 5, 2023, 8 am CDT, Hall A |
Analysis of fruquintinib adverse events of special interest
from phase 3 of the FRESCO-2 study |
Cathy Eng, Vanderbilt-Ingram Cancer Center |
Abstract # 3601 Poster SessionGastrointestinal Cancer–Colorectal
and AnalMonday, June 5, 2023, 8 am CDT, Hall A |
A phase IV study to evaluate the safety of fruquintinib in
Chinese real-world clinical practice |
Jin Li, Tongji University Shanghai East Hospital |
Abstract # e15568Publication OnlyGastrointestinal Cancer–Colorectal
and Anal |
Fruquintinib plus sintilimab in patients with either
treatment-naive or previously first line treated metastatic
clear-cell renal cell carcinoma (ccRCC): Results from a
multicenter, single-arm phase 2 study |
Dingwei Ye, Fudan University Shanghai Cancer Center |
Abstract # e16514 Publication OnlyGenitourinary Cancer—Kidney and
Bladder |
Efficacy and safety of fruquintinib plus investigator's
choice of chemotherapy as second-line therapy in metastatic
colorectal cancer: A multicenter, single-arm phase 2
trial |
Wensi Zhao, Renmin Hospital of Wuhan University |
Abstract # 3582 Poster SessionGastrointestinal Cancer–Colorectal
and AnalMonday, June 5, 2023, 8 am CDT, Hall A |
Fruquintinib plus oxaliplatin combined with S-1 (SOX) as
neoadjuvant therapy for locally advanced gastric adenocarcinoma
(FRUTINEOGA): a multicenter, phase II study. |
Liucheng Wu, Guangxi Medical University Cancer Hospital |
Abstract # e16063Publication OnlyGastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
Association of neutrophil/lymphocyte ratio and IFN-γ with
clinical response and survival in patients with MSS/pMMR mCRC
treated with anti-PD-1 and VEGF inhibitors |
Zhuqing Liu, Tongji University School of Medicine |
Abstract # e14610Publication OnlyDevelopmental
Therapeutics—Immunotherapy |
Efficacy and safety of radiation therapy combined with
anti-angiogenic agents and immunotherapy for MSS/pMMR metastatic
colorectal cancer: A real-world study |
Zhenyu Lin, Tongji Medical College |
Abstract # e15559Publication OnlyGastrointestinal Cancer—Colorectal
and Anal |
A phase II study of fruquintinib in the first- (1L) or
second-line (2L) treatment of unresectable metastatic soft tissue
sarcoma |
Zhiguo Luo, Fudan University Shanghai Cancer Center |
Abstract # e23547Publication OnlySarcoma |
Quality of life, effectiveness, and compliance of
fruquintinib in the treatment of metastatic colorectal cancer:
Results from a prospective real-world study. |
Jun Zhang, Reijin Hospital |
Abstract # e15557Publication OnlyGastrointestinal Cancer–Colorectal
and Anal |
Fruquintinib versus fruquintinib combined with PD-1
inhibitors for metastatic colorectal cancer: Real-world
data |
Lina He, Shanghai Jiao Tong University |
Abstract # e15592 Publication OnlyGastrointestinal
Cancer–Colorectal and Anal |
Phase II study of fruquintinib as second or further-line
therapy for patients with advanced biliary tract
cancer |
Pengfei Zhang, West China Hospital |
Abstract # e16161Publication OnlyGastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
A phase I/IIa study of cetuximab combined with fruquintinib
in the previously treated RAS/BRAF wild-type metastatic colorectal
cancer: Results of the CEFRU study |
Yong Li, Traditional Chinese Medicine Hospital of Guangdong |
Abstract # e15558Publication OnlyGastrointestinal Cancer–Colorectal
and Anal |
SURUFATINIB |
A multicenter, single-arm phase 2 study of surufatinib plus
toripalimab for patients with locally advanced or metastatic
radioactive iodine-refractory differentiated thyroid
cancer |
Dongmei Ji, Fudan University Shanghai Cancer Center |
Abstract # 6089Poster SessionHead and Neck Cancer Monday, June 5,
2023, 1:15 pm CDT, Hall A |
A multicenter, single-arm, phase 2 study of surufatinib
plus toripalimab for patients with advanced endometrial
cancer |
Guangwen Yuan, Cancer Hospital Chinese Academy of Medical
Sciences |
Abstract # 5609Poster SessionGynecologic CancerMonday, June 5,
2023, 1:15 pm CDT, Hall A |
A phase 1b/2 study of surufatinib plus camrelizumab,
nab-paclitaxel, and S-1 (NASCA) as first-line therapy for
metastatic pancreatic adenocarcinoma (mPDAC) |
Guanghai Dai, The Fifth Medical Center of the PLA General
Hospital |
Abstract # 4142 Poster SessionGastrointestinal
Cancer—Gastroesophageal, Pancreatic, and HepatobiliaryMonday, June
5, 2023, 8:00 am CDT, Hall A |
A phase Ib/II study to evaluate surufatinib combined with
camrelizumab and chemotherapy in the second-line treatment of
advanced colorectal cancer: Phase Ib results |
Sheng Li, Department of Oncology, Jiangsu Cancer Hospital |
Abstract # 3555 Poster SessionGastrointestinal Cancer–Colorectal
and AnalMonday, June 5, 2023, 8 am CDT, Hall A |
Phase 1b/2 study of surufatinib in combination with
docetaxel as second-line treatment of advanced driver-gene negative
non-squamous non-small cell lung cancer (NSCLC) |
Wei Jiang, Guangxi Medical University Cancer Hospital |
Abstract # e21087 Publication OnlyLung Cancer—Non-Small Cell
Metastatic |
Pathologic exploration of neuroendocrine differentiation in
carcinomas |
Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences |
Abstract # e16238Publication OnlyGastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
A phase II study of surufatinib in patients with
osteosarcoma and soft tissue sarcoma who have failed in standard
chemotherapy |
Xing Zhang, Sun Yat-sen University Cancer Center |
Abstract # e23540Publication OnlySarcoma |
HMPL-453 |
A phase 2 study of HMPL-453, a selective FGFR tyrosine
kinase inhibitor (TKI), in patients with previously treated
advanced cholangiocarcinoma containing FGFR2 fusions |
Jianming Xu, Fifth Medical Center, Chinese PLA General
Hospital |
Abstract # e16118 Publication OnlyGastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary |
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an
innovative, commercial-stage, biopharmaceutical company. It is
committed to the discovery and global development and
commercialization of targeted therapies and immunotherapies for the
treatment of cancer and immunological diseases. It has
approximately 5,000 personnel across all its companies, at the
center of which is a team of about 1,800 in oncology/immunology.
Since inception it has focused on bringing cancer drug candidates
from in-house discovery to patients around the world, with its
first three oncology drugs now approved and marketed in China. For
more information, please visit: www.hutch-med.com or follow us on
LinkedIn.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the “safe harbor” provisions of
the U.S. Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect HUTCHMED’s current expectations
regarding future events, including its expectations regarding the
therapeutic potential of fruquintinib, surufatinib, and HMPL-453,
the further clinical development for fruquintinib, surufatinib, and
HMPL-453, its expectations as to whether any studies on
fruquintinib, surufatinib and HMPL-453 would meet their primary or
secondary endpoints, and its expectations as to the timing of the
completion and the release of results from such studies.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding enrollment rates and the timing and availability of
subjects meeting a study’s inclusion and exclusion criteria;
changes to clinical protocols or regulatory requirements;
unexpected adverse events or safety issues; the ability of
fruquintinib, surufatinib and HMPL-453, including as a combination
therapy, to meet the primary or secondary endpoint of a study, to
obtain regulatory approval in different jurisdictions and to gain
commercial acceptance after obtaining regulatory approval; the
potential market of fruquintinib, surufatinib and HMPL-453 for a
targeted indication; the sufficiency of funding; and the impact of
the COVID-19 pandemic on general economic, regulatory and political
conditions. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. For further discussion of these
and other risks, see HUTCHMED’s filings with the U.S. Securities
and Exchange Commission, The Stock Exchange of Hong Kong Limited
and on AIM. HUTCHMED undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise.
CONTACTS
Investor Enquiries |
|
Mark Lee, Senior Vice President |
+852 2121 8200 |
|
Annie Cheng, Vice President |
+1 (973) 306 4490 |
|
|
|
Media Enquiries |
|
Americas – Brad Miles,
Solebury Strategic Communications |
+1 (917) 570 7340 (Mobile) /
bmiles@soleburystrat.com |
|
Europe – Ben Atwell / Alex Shaw,
FTI Consulting |
+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) /
HUTCHMED@fticonsulting.com |
|
Asia – Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
|
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure
Gordon |
+44 (20) 7886 2500 |
1 Sun Q, et al. (2014) Discovery of fruquintinib, a potent and
highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine
kinases for cancer therapy, Cancer Biol Ther. 2014 15:12,
1635-1645. Doi: 10.4161/15384047.2014.964087 |
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